628713
White Plains Hospital Center Blood Bank — FEI 2470900
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- White Plains, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9227 | 21 CFR 606.171(a) | BPDR - procedures |